Friday, July 15, 2005

Cox 2 News from Canada: Bextra, Celebrex and Vioxx

News from Canada with an important link below:

Immediate actions Health Canada will take include:

  • Manufacturers of all NSAIDs currently on the market in Canada will be requested to provide updated patient safety information for these products. This would include Celebrex, which is currently available in Canada by prescription, and ibuprofen products currently available over-the-counter;
  • Health Canada will continue its assessment of whether Bextra should be returned to the Canadian market after sales were voluntarily suspended in April 2005. The recommendations from the panel will be a key factor in the Department's final decision, which is expected in the coming weeks;
  • Health Canada will be conducting further analysis and communicating to provincial health regulators the panel's recommendations on current over-the-counter availability of some ibuprofen products, in particular to address the possibility of inappropriate, long-term use of these products;
  • Health Canada will issue guidance to manufacturers, establishing standards for the risk and benefit information that must be included in product labelling of NSAIDs.
The report can be found here.

In the report, Health Canada reported the following:

Eight to five that Bextra NOT be allowed back on the market. The majority:
a) felt that there was not sufficient information available about the cardiovascular risk associated with Bextra,
b) was concerned with the possible increase in a rare but serious skin disorder, and
c) felt that numerous other NSAIDs with more complete information about benefits and harms are already on the market.

The minority who voted that Bextra should be marketed felt that a) the increased risk of cardiovascular disease caused by Bextra is likely to be similar to that of other Cox-2 selective inhibitors, b) the number of patients suffering severe adverse skin reactions is very small and similar to many other drugs still on the market, and c) some patients will benefit from having another anti-inflammatory agent available. Those who voted for the marketing of Bextra felt that it should only be marketed as a third-line anti-inflammatory agent to be used if others have failed.

It's worth reading.